WO2017208217A2 - Compositions de cétone en c5, et procédés associés, pour une supplémentation thérapeutique et efficace - Google Patents

Compositions de cétone en c5, et procédés associés, pour une supplémentation thérapeutique et efficace Download PDF

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WO2017208217A2
WO2017208217A2 PCT/IB2017/054679 IB2017054679W WO2017208217A2 WO 2017208217 A2 WO2017208217 A2 WO 2017208217A2 IB 2017054679 W IB2017054679 W IB 2017054679W WO 2017208217 A2 WO2017208217 A2 WO 2017208217A2
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subject
ketone
pharmaceutically acceptable
chelate
ester
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WO2017208217A3 (fr
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Shawn Wells
Sam BEELER
Kylin LIAO
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Aspi Ip Holder LLC
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Aspi Ip Holder LLC
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Priority to US16/306,412 priority Critical patent/US11337945B2/en
Publication of WO2017208217A2 publication Critical patent/WO2017208217A2/fr
Publication of WO2017208217A3 publication Critical patent/WO2017208217A3/fr
Anticipated expiration legal-status Critical
Priority to US17/732,482 priority patent/US20220249419A1/en
Priority to US18/157,788 priority patent/US20230149329A1/en
Priority to US18/319,334 priority patent/US20230364043A1/en
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis

Definitions

  • BHB ⁇ -hydroxybutyrate
  • the heart, brain and kidney are the three organs with the highest activity of enzymes utilizing ketone bodies (Ardawi and Newsholme 1982). For instance, studies have shown an improvement in the neurological status of a newborn with pyruvate carboxylase deficiency during treatment with triheptanoin (C7 ketone) (Mochel et al 2005; Roe and Mochel 2006).
  • the subject disclosure provides methods for increasing mental and/or physical performance levels in a subject, the methods comprising administering to the subject a therapeutically effective amount of a C5 -ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof.
  • the methods described aid Kreb cycle function and/or anaplerosis in a subject being treated with the described compositions.
  • the C5-ketone body is ⁇ -ketopentanoate.
  • the mental performance level being increased is a measure of well-being and/or focus.
  • the physical performance level being increased is energy.
  • the subject disclosure provides methods for increasing blood ketone levels in a subject, the methods comprising administering to the subject a therapeutically effective amount of a C5-ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof.
  • the C5-ketone body is ⁇ -hydroxypentanoate.
  • the subject disclosure provides methods for treating and/or preventing one or more of obesity, diabetes, metabolic syndrome, Alzheimer's disease, Chronic Fatigue Syndrome (CFS), aging, fibromyalgia, dyslipidemia, hypercholesterolemia, dyslipidemia, Parkinson's disease, migraines, Traumatic Brain Injury (TBI), Attention Deficit Disorder (ADD)/Attention Deficit Hyperactivity Disorder (ADHD), Cancer, Cardiovascular Disease (CVD)/ Coronary Artery Disease (CAD), Chronic Pain, neuralgia, depression, amyotrophic lateral sclerosis (ALS), epilepsy, Insufficient Cellular Energy (ICE) and mitochondrial dysfunction in a subject, the methods comprising administering to the subject a therapeutically effective amount of a C5-ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof.
  • CFS Chronic Fatigue Syndrome
  • fibromyalgia dyslipidemia
  • hypercholesterolemia dyslipidemia
  • Parkinson's disease migraines
  • Traumatic Brain Injury (TBI) Attention Deficit Disorder
  • the subject disclosure provides methods for decreasing blood glucose levels and/or increasing BHB levels in a subject, the methods comprising administering to the subject a therapeutically effective amount of a C5 -ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof.
  • the C5-ketone body is ⁇ -ketopentanoate.
  • the subject disclosure provides methods for aiding in weight loss in a subject, the methods comprising administering to the subject a therapeutically effective amount of a C5 -ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof.
  • the subject disclosure provides methods for lowering exertion during exercise in a subject, the methods comprising administering to the subject a therapeutically effective amount of a C5-ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof.
  • compositions comprising a therapeutically effective amount of C5-ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof.
  • the compositions may be for the treatment of the diseases and conditions described herein.
  • the compositions further include an acceptable carrier.
  • the C5 -ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof concentration is from about 1 gram to about 50 grams.
  • Figure 1 illustrates the metabolism of C5 ketones in their racemic mixture and dissociated into their respective isoforms.
  • Figure 2 illustrates C4 ketogenesis and C5 ketogenesis in the liver. Numbers refer to the following enzymes: 3-ketoacyl-CoA thiolase (1); HMG-CoA synthase (2); HMG-CoA lyase (3); and ⁇ -hydroxybutyrate dehydrogenase (4). The figure also shows the link between propionyl- CoA and the CAC via anaplerosis.
  • Figure 3 illustrates the metabolism of triheptanoin into C5 ketone bodies BHP and BKP, which ultimately get transported out of the mitochondria.
  • Figure 4 shows a graph of blood glucose level with BKP administration.
  • Figure 5 shows a graph of blood ketone level with BHP administration.
  • Figure 6 shows a graph of visual analog scales (VAS) of well-being with BKP administration.
  • Figure 7 shows a graph of VAS of energy with BKP administration.
  • Figure 8 shows a graph of VAS of focus with BKP administration.
  • the present disclosure pertains to compositions and methods for the treatment and/or prevention of one or more of obesity; diabetes; metabolic syndrome; Alzheimer's disease; Chronic Fatigue Syndrome (CFS); aging; fibromyalgia; dyslipidemia; hypercholesterolemia; dyslipidemia; Parkinson's disease; migraines; Traumatic Brain Injury (TBI); Attention Deficit Disorder (ADD)/Attention Deficit Hyperactivity Disorder (ADHD); Cancer, such as for example, glioblastoma; Cardiovascular Disease (CVD)/ Coronary Artery Disease (CAD); Chronic Pain; neuralgia; depression; amyotrophic lateral sclerosis (ALS); epilepsy; Insufficient Cellular Energy (ICE) and mitochondrial dysfunction.
  • the present disclosure also pertains to methods for increasing mental and/or physical performance levels.
  • C5 ketones There are many potential forms of C5 ketones. C5 ketones could be unbound in their "free acid” state; or C5 ketones can be salts (e.g. sodium, calcium, magnesium, etc.), esters (e.g. glycerol), chelates (e.g. amino acids), or any other chemical variant with C5 ketones attached. Further, C5 ketones can be in combination with other compounds, including other carbon length ketones themselves. Two C5 ketones are ⁇ -hydroxypentanoate (BHP) [R, S, & RS isoforms] and ⁇ - ketopentanoate (BKP) (also known as 3 -hydroxy valerate and 3-ketovalerate).
  • BHP ⁇ -hydroxypentanoate
  • BKP ⁇ - ketopentanoate
  • C5 ketones are homologues of physiological ketone bodies, ⁇ -hydroxybutyrate (BHB) and acetoacetate.
  • C5 ketone bodies are naturally formed in the liver from the partial oxidation of odd chain fatty acids (e.g. C-7, heaptanoic acid, like macadamia nut oil).
  • C5 ketones have been shown to occur in trace amounts in human plasma and most plants. They are derived from the oxidation in liver of the R-moiety of R,S-l,3-pentanediol, a potential nutrient. Whether administered by bolus or constant infusion, the two substrates are interconverted and rapidly metabolized in an animal model.
  • ⁇ -hydroxypentanoate (BHP) and ⁇ -ketopentanoate (BKP) are well metabolized in animals without apparent intolerance to a large supply of propionyl-CoA.
  • C5-ketone bodies ((R)-P- hydroxypentanoate and ⁇ -ketopentanoate) are very rapidly used when administered intravenously at doses corresponding to 75% of the energy requirement (Leclerc et al 1995).
  • C5 ketone bodies are interconverted by mitochondrial BHB dehydrogenase.
  • C5 ketone bodies are converted to propionyl- CoA (which is anaplerotic).
  • Peripheral tissues have a high capacity to utilize exogenous C5 ketone bodies, especially heart, kidney, and brain, which have high activities of 3-oxoacid-CoA transferase.
  • C5 ketone bodies provide a unique benefit in promoting increases in mental and physical performance, aiding Kreb cycle function, and contributing as a unique aide in various diseased populations (e.g. obesity, diabetes, cancer, cardiovascular disease, epilepsy, Alzheimer's, Parkinson's, etc.) and anaplerotic scenarios.
  • C5 ketone bodies also aid in weight loss/fat loss.
  • the terms “including”, “includes”, “having”, “has”, “with”, or variants thereof, are intended to be inclusive similar to the term “comprising.”
  • the term “subject” refers to an animal. Typically, the terms “subject” and “patient” may be used interchangeably herein in reference to a subject.
  • a "subject” includes an animal that is being treated for conditions described in the present disclosure, such as, but not limited to, obesity, diabetes, metabolic syndrome, Alzheimer's disease, Chronic Fatigue Syndrome (CFS), aging, fibromyalgia, dyslipidemia, hypercholesterolemia, dyslipidemia, Parkinson's disease, migraines, Traumatic Brain Injury (TBI), Attention Deficit Disorder (ADD)/ Attention Deficit Hyperactivity Disorder (ADHD), Cancer, Cardiovascular Disease (CVD)/ Coronary Artery Disease (CAD), Chronic Pain, neuralgia, depression, amyotrophic lateral sclerosis (ALS), and epilepsy, Insufficient Cellular Energy (ICE) and mitochondrial dysfunction; or the recipient of a mixture of components or compositions as described herein.
  • the term "animal,” includes, but is not limited to, a mammal, such as a mouse, rat, dog, guinea pig, cow, horse, chicken, cat, rabbit, pig, monkey, chimpanzee, and human.
  • an effective amount or “therapeutically effective amount” means that amount of active compound that elicits the biological or medicinal response in a tissue system, animal or human that is being sought by a researcher, veterinarian, medical doctor or other clinician, which includes alleviation of one or more of the symptoms of the disease or disorder being treated; reduction of the severity of one or more of the symptoms of the disease or disorder being treated; or otherwise provides the desired effect.
  • the precise dosage will vary according to a variety of factors such as subject- dependent variables (e.g., age, medical history, etc.), the disorder or condition, and the treatment being affected.
  • therapeutically effective amount means that amount of the combination of agents taken together so that the combined effect elicits the desired biological or medicinal response.
  • therapeutically effective amount of co-therapy comprising administration of a C5-ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof, and other carbon length ketones would be the amount of the C5-ketone body and the amount of the other carbon length ketone(s) that, when taken together or sequentially, have a combined effect that is therapeutically effective.
  • the amount of C5-ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof, and other carbon length ketone, individually may or may not be therapeutically effective.
  • pharmaceutically acceptable means approved by a regulatory agency of the Federal or a state government or listed in the U.S. Pharmacopeia or other generally recognized pharmacopeia for use in animals and/or in humans.
  • “Pharmaceutically acceptable salt” refers to a salt of a compound of the disclosure that is pharmaceutically acceptable and that possesses the desired pharmacological activity of the parent compound.
  • Such salts include: (1) acid addition salts, formed with inorganic acids such as hydrochloric acid, hydrobromic acid, sulfuric acid, nitric acid, phosphoric acid, and the like; or formed with organic acids such as acetic acid, propionic acid, hexanoic acid, cyclopentanepropionic acid, glycolic acid, pyruvic acid, lactic acid, malonic acid, succinic acid, malic acid, maleic acid, fumaric acid, tartaric acid, citric acid, benzoic acid, 3-(4- hydroxybenzoyl)benzoic acid, cinnamic acid, mandelic acid, methanesulfonic acid, ethanesulfonic acid, 1,2-ethane-disulfonic acid, 2-hydroxyethanesulfonic acid, benz
  • compositions comprising one or more C5- ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof, as the active ingredient.
  • the compositions described can also be in the form of a pharmaceutical composition comprising one or more pharmaceutically acceptable carriers described herein.
  • the compounds and compositions of the disclosure can be used to treat, alleviate, inhibit or prevent the diseases and conditions further described herein. Further, the compounds and compositions of the disclosure can be used for increasing mental and/or physical performance levels in a subject or for aiding in weight loss.
  • the C5 ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration is from about 1 gram to about 50 grams.
  • the C5 -ketone, or pharmaceutically acceptable salt, ester, or chelate thereof concentration is from about 1 gram to about 40 grams. In some embodiments, the C5- ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration is from about 1 gram to about 30 grams. In some embodiments, the C5 -ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration is from about 1 gram to about 20 grams. In some embodiments, the C5 -ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration is from about 1 gram to about 10 grams.
  • the C5-ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration is from about 10 grams to about 50 grams. In some embodiments, the C5-ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration is from about 20 grams to about 50 grams. In some embodiments, the C5 -ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration is from about 30 grams to about 50 grams. In some embodiments, the C5-ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration is from about 40 grams to about 50 grams. In some embodiments, the C5-ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration is about 10 grams.
  • carrier refers to a diluent, adjuvant, excipient, and/or vehicle with which the compositions are administered.
  • Such pharmaceutical carriers can be sterile liquids, such as water and oils, including those of petroleum, animal, vegetable or synthetic origin, such as peanut oil, soybean oil, mineral oil, sesame oil and the like. Saline solutions and aqueous dextrose and glycerol solutions can also be employed as liquid carriers, particularly for injectable solutions.
  • Suitable pharmaceutical excipients include starch, glucose, sucrose, gelatin, lactose, malt, rice, flour, chalk, silica gel, sodium stearate, glycerol monostearate, talc, sodium chloride, glycerol, propylene, glycol, water, ethanol and the like.
  • the pharmaceutical composition(s) may also contain wetting or emulsifying agents or suspending/diluting agents, or pH buffering agents, or agents for modifying or maintaining the rate of release of the formulations.
  • the compositions can take the form of solutions, suspensions, emulsion, tablets, pills, capsules, powders, gels, creams, sustained-release formulations and the like.
  • Formulations can include standard carriers such as pharmaceutical grades of mannitol, lactose, sodium saccharine, starch, magnesium stearate, cellulose, magnesium carbonate, etc. Such compositions will contain an effective amount of the active ingredient(s) together with a suitable amount of carrier so as to provide the proper form to the subject based on the mode of administration to be used.
  • the compositions are packaged in solutions of sterile isotonic aqueous buffer.
  • the composition may also include a solubilizing agent.
  • the components of the composition are supplied either separately or mixed together in unit dosage form, for example, as a dry lyophilized powder or concentrated solution in a hermetically sealed container such as an ampoule or sachet indicating the amount of active agents.
  • the composition can be dispensed with an infusion bottle containing sterile pharmaceutical grade water or saline.
  • an ampoule of sterile water or saline can be provided so that the ingredients may be mixed prior to injection.
  • a packaging material may be biologically inert or lack bioactivity, such as plastic polymers, silicone, etc. and may be processed internally by the subject without affecting the effectiveness of the components packaged and/or delivered therewith. Additionally, the compositions and components may be packaged with additional agents.
  • the C5-ketones utilized in the methods and compositions may be provided in an isolated or purified form. Further, synthetic variants of the C5 -ketones may be utilized, either individually or in combination with other synthetic C5 -ketone variants, or in combination with non-synthetic variants.
  • kits comprising one or more C5-ketone or pharmaceutically acceptable salt, ester, or chelate thereof, as described herein.
  • the kits may further be used in the methods described herein.
  • the kits may also include at least one reagent and/or instructions for their use.
  • the kit may include one or more containers filled with reagent(s) and/or one or more components of the disclosure.
  • One or more container of the kits provided may also comprise a C5 -ketone, preferably in a purified form.
  • one or more container of the kits provided may also comprise another carbon length ketone, preferably in a purified form.
  • kits may also comprise a control composition, such as reagents that lack a ketone for use as a control reagent in experimentation.
  • detection or labeling methodologies can be used in the kits provided when utilized in an experimental or laboratory setting.
  • aspects of the present disclosure are further directed to methods for the treatment and/or prevention of one or more of obesity, diabetes, metabolic syndrome, Alzheimer's disease, Chronic Fatigue Syndrome (CFS), aging, fibromyalgia, dyslipidemia, hypercholesterolemia, dyslipidemia, Parkinson's disease, migraines, Traumatic Brain Injury (TBI), Attention Deficit Disorder (ADD)/ Attention Deficit Hyperactivity Disorder (ADHD), Cancer, Cardiovascular Disease (CVD)/ Coronary Artery Disease (CAD), Chronic Pain, neuralgia, depression, amyotrophic lateral sclerosis (ALS), and epilepsy, Insufficient Cellular Energy (ICE) and mitochondrial dysfunction, which involve administering a therapeutically effective amount of a C5 -ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof, or pharmaceutical compositions of the present disclosure, to a subject, preferably a mammal, and most preferably a human.
  • CFS Chronic Fatigue Syndrome
  • fibromyalgia dyslipidemia
  • C5-ketones have potential to work directly on the mitochondria, therefore, in some embodiments, the C5 -ketones and related methods described by this disclosure are useful for treating mitochondrial dysfunction. As such, C5 -ketones are particularly useful in treating cancers that result from mitochondrial dysfunction, such as, for example, glioblastoma.
  • aspects of the present disclosure may also be directed to methods for increasing blood ketone levels in a subject, comprising administering to the subject a therapeutically effective amount of a C5-ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof, such as, for example, ⁇ -hydroxypentanoate (BHP).
  • a C5-ketone body or pharmaceutically acceptable salt, ester, or chelate thereof, such as, for example, ⁇ -hydroxypentanoate (BHP).
  • a further aspect of the present disclosure may be directed to methods for decreasing blood glucose levels in a subject, comprising administering to the subject a therapeutically effective amount of a C5-ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof, such as, for example, ⁇ -ketopentanoate (BKP).
  • a C5-ketone body or pharmaceutically acceptable salt, ester, or chelate thereof, such as, for example, ⁇ -ketopentanoate (BKP).
  • BKP ⁇ -ketopentanoate
  • aspects of the present disclosure are also directed to methods for increasing mental and/or physical performance levels which involve administering a therapeutically effective amount of a C5-ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof, or pharmaceutical compositions of the present disclosure, to a subject, preferably a mammal, and most preferably a human.
  • the C5-ketone body is ⁇ -ketopentanoate.
  • the mental performance level being increased may be a measure of well-being and/or focus.
  • the physical performance level being increased may be a measure of energy.
  • the subject disclosure provides methods for aiding in weight loss in a subject, the methods comprising administering to the subject a therapeutically effective amount of a C5 -ketone body, or pharmaceutically acceptable salt, ester, or chelate thereof.
  • the subject disclosure provides methods for lowering exertion during exercise in a subject, the methods comprising administering to the subject a therapeutically effective amount of a C5-ketone body (e.g., ⁇ -ketopentanoate), or pharmaceutically acceptable salt, ester, or chelate thereof.
  • the exercise is moderate intensity exercise and in other embodiments, the exercise is high intensity exercise.
  • Moderate intensity exercise includes, for example, running, cycling, rowing, circuit training, and yogo.
  • High intensity exercise includes, for example, sprinting, hockey, soccer, baseball, football, basketball, resistance training and boxing.
  • the C5-ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration utilized in the methods described is from about 1 gram to about 50 grams. In some embodiments, the C5-ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration utilized in the methods described is from about 1 gram to about 40 grams. In some embodiments, the C5-ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration utilized in the methods described is from about 1 gram to about 30 grams. In some embodiments, the C5-ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration utilized in the methods described is from about 1 gram to about 20 grams.
  • the C5-ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration utilized in the methods described is from about 1 gram to about 10 grams. In some embodiments, the C5-ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration utilized in the methods described is from about 10 grams to about 50 grams. In some embodiments, the C5-ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration utilized in the methods described is from about 20 grams to about 50 grams. In some embodiments, the C5-ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration utilized in the methods described is from about 30 grams to about 50 grams.
  • the C5-ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration utilized in the methods described is from about 40 grams to about 50 grams. In some embodiments, the C5-ketone, or pharmaceutically acceptable salt, ester, or chelate thereof, concentration utilized in the methods described is about 10 grams.
  • Preventing refers to a reduction in risk of acquiring disorder (i.e., causing at least one of the clinical symptoms of the disease/disorder not to develop in a subject that may be predisposed to the disorder but does not yet experience or display symptoms of the disorder).
  • Treating” or “treatment” of any disorder refers, in one embodiment, to ameliorating the disorder (i.e., arresting or reducing the development of the disorder (e.g., Alzheimer's disease) or at least one of the clinical symptoms thereof).
  • “treating” or “treatment” refers to ameliorating at least one physical parameter, which may not be discernible by the subject.
  • “treating” or “treatment” refers to modulating the disorder, either physically, (e.g., stabilization of a discernible symptom), physiologically, (e.g., stabilization of a physical parameter), or both.
  • “treating” or “treatment” refers to delaying the onset of the disorder.
  • Administration can be locally (confined to an area of body) and/or systemically in the subject. It may be desirable to administer the C5-ketones, or pharmaceutical compositions comprising same, locally to the area in need of treatment.
  • This method of administration may be achieved by, for example, and not by way of limitation, local infusion, topical application, by injection, by catheter, or by means of an implant (e.g., a porous membrane).
  • Administration may also be orally, such as but not limited to, by way of pills, capsules, liquid, vapors, or powders.
  • aspects of this disclosure can provide more than two active ingredient components in the mixtures of compositions herein disclosed.
  • the disclosed methods can comprise the simultaneous or separate administration of multiple active ingredients.
  • embodiments may further include the administration of a third, fourth, etc. active ingredient, wherein the third, fourth, etc. active ingredient is administered separately, but at the same time as the other active ingredients, or hours or days after the first administration of active ingredients.
  • the C5-ketones, or pharmaceutical composition containing them can be delivered in a controlled release system.
  • Such methods may include the use of a pump for administration (e.g., use of an intravenous drip).
  • compositions of the invention may also be utilized in pharmaceutically acceptable compositions in the methods provided herein.
  • compositions described herein for therapeutic purposes without undue experimentation based on the teachings provided throughout the specification.
  • amount of active ingredients or pharmaceutical compounds of the invention which will be effective in the treatment, inhibition and/or prevention of the diseases and/or conditions described herein can be determined by standard clinical techniques. Additionally, in vitro assays may be employed to help identify optimal dosage ranges. The precise dose to be utilized will also depend on the route of administration, and the seriousness of the disease or condition, and should also be decided according to the sound medical judgment of the clinician and each patient's individual circumstances.
  • the specific therapeutically effective dosage level for any particular patient will depend upon a variety of factors including: the type and degree of the response to be achieved; the specific composition and other agent(s), if any, employed; the age, weight, general health, sex and diet of the patient; the time of administration, route of administration, and rate of excretion of the composition; the duration of the treatment; other drugs used in combination or coincidental with the composition; and any other factors well known in the medical arts.
  • Effective dosages may also be extrapolated from dose-response curves derived from in vitro or animal model testing systems.
  • Example 1 BHP and BKP effects on subject blood glucose and ketone levels; and subject well-being, energy and focus
  • VAS visual analog scales
  • Blood ketones were measured via finger prick using an Abbott Precision device which determines mMol of BHB. Blood glucose was measures using Abbott Precision glucose strips and was measured in mg/dL.
  • Results are summarized in Table 1 and Figure 4 ( Figure 4 shows a graph of blood glucose level with BKP administration), Table 2 and Figure 5 (Figure 5 shows a graph of blood ketone level with BHP administration), Table 3 and Figure 6 ( Figure 6 shows a graph of VAS of well- being with BKP administration), Table 4 and Figure 7 ( Figure 7 shows a graph of VAS of energy with BKP administration), and Table 5 and Figure 8 ( Figure 8 shows a graph of VAS of focus with BKP administration).
  • Example 2 C 5 -ketone administration as a method to lower exertion during exercise
  • BKP is able to lower perceived exertion at both moderate and high intensity exercise compared to a placebo. See Table 6, which shows the Borg Rating of Perceived Exertion (RPE), which is a way of measuring physical activity intensity level. Perceived exertion is how hard one feels like the body is working.
  • RPE Perceived Exertion

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Abstract

La présente invention concerne des compositions et des procédés pour le traitement et/ou la prévention d'un ou de plusieurs de l'obésité, du diabète, du syndrome métabolique, de la maladie d'Alzheimer, du syndrome de fatigue chronique (CFS), du vieillissement, de la fibromyalgie, de la dyslipidémie, de l'hypercholestérolémie, la dyslipidémie, de la maladie de Parkinson, des migraines, d'une lésion cérébrale traumatique (TBI), d'un trouble déficitaire de l'attention (ADD)/un trouble déficitaire de l'attention avec hyperactivité (TDAH), d'un cancer, d'une maladie cardiovasculaire (CVD)/une maladie coronarienne (CAD), de la douleur chronique, d'une névralgie, de la dépression, de la sclérose latérale amyotrophique (SLA), et de l'épilepsie, d'une énergie cellulaire insuffisante (ICE) et d'un dysfonctionnement mitochondrial. La présente invention concerne également des procédés d'augmentation des niveaux de performance mentale et/ou physique et/ou de réduction l'effort pendant l'exercice chez un sujet par l'administration de cétones en C5.
PCT/IB2017/054679 2016-06-01 2017-08-01 Compositions de cétone en c5, et procédés associés, pour une supplémentation thérapeutique et efficace Ceased WO2017208217A2 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
US16/306,412 US11337945B2 (en) 2016-06-01 2017-08-01 C5 ketone compositions, and related methods, for therapeutic and performance supplementation
US17/732,482 US20220249419A1 (en) 2016-06-01 2022-04-28 C5 ketone compositions, and related methods, for therapeutic and performance supplementation
US18/157,788 US20230149329A1 (en) 2016-06-01 2023-01-20 C5 ketone compositions and related methods for therapeutic and performance supplementation
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